510(k) K123957
K123957 is an FDA 510(k) premarket notification submitted by Smiths Medical International , Ltd. for the device "PNEUPAC PARAPAC PLUS". The FDA issued a decision of Substantially Equivalent on September 16, 2013. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Smiths Medical International , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2013
- Date Received
- December 21, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Powered (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5925
- Review Panel
- AN
- Submission Type